Chi's Enterprise Inc – FDA Warning Letter, Oct 4, 2017

On April 30, 2018, the FDA issued a Warning Letter to Chi's Enterprise, Inc. following an inspection from September to October 2017. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering the products adulterated under 21 U.S.C. § 342(g)(1). The company had not submitted a written response to the FDA 483.

Key violations include: 1. **Failure to establish and follow written quality control procedures (21 CFR 111.103):** Procedures lacked provisions for approving/rejecting packaged dietary supplements and conducting material reviews/disposition decisions for contract-manufactured products. 2. **Failure to establish required specifications (21 CFR 111.70(a)):** This includes a lack of component specifications (identity, purity, strength, composition, contamination limits) for ingredients like Myomin, Astragalus, and Curcuma extracts (21 CFR 111.70(b)), dietary supplement label specifications (21 CFR 111.70(d)), specifications for incoming bulk products from contract manufacturers (21 CFR 111.70(f)), and specifications for packaging and labeling finished products (21 CFR 111.70(